Doxorubicin Adverse Reaction, Febrile Neutropenia, Hospitalization-Associated Infection, Sarcoma
Conditions
Keywords
febrile neutropenia, acupuncture, sarcoma, doxorubicin, hospitalization
Brief summary
Chemotherapy-induced febrile neutropenia (CIFN) is a dangerous complication of many chemotherapy drugs, with current treatment with granulocyte colony-stimulating factors (G-CSFs) accompanied by adverse effects, primarily muscle and bone pain. Adult patients with sarcoma treated with doxorubicin-based chemotherapy have a high risk (\>40%) for developing CIFN. Acupuncture has been shown to have a potentially myelo-protective effect on bone marrow during chemotherapy, though its effect on the incidence of CIFN-related hospitalization has yet to be examined. In the proposed study, patients with sarcoma will be randomly allocated (in a ratio of 1:1) to Group A, receiving acupuncture during cycles 1, 3, and 5; or Group B, during cycles 2, 4, and 6, with the study oncologist blinded regarding allocation. Acupuncture will be administered on the first day (d1) and the 8th day (d8) of the chemotherapy cycles, with press-tack needles on d1 to d8, and patients will be taught to self-treat with acupressure from d8 to the next cycle. The incidence and duration of hospitalization due to CIFN will be examined, as will adherence to the chemotherapy regimen; G-CSF-related pain; and other outcomes using 3 quality-of-life-focused questionnaires. The study findings will have important implications regarding the role of acupuncture in the treatment of patients treated with chemotherapy drugs with a high risk for CIFN, such as those used in the treatment of sarcoma.
Interventions
DEVICEAcupuncture
Acupuncture will be administered bilaterally on points PC6, LI 4, CV6, SP6, SP10 and ST36 on the first day of each cycle (d1), prior to administration of chemotherapy; and on d8, each session lasting between 30 to 45 minutes. Patients will continue from d1 to d8 with press-tack acupuncture needles on points PC 6, LI4, SP 6 and ST 36. On d8, patients will again undergo acupuncture, and continue with self-acupressure on the same points as the press-tack needles, until the next chemotherapy cycle.
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Masking description
he treating oncologist will be blinded as to the patient's allocation and study intervention during each cycle of chemotherapy.
Intervention model description
Participating patients will be treated with one of the following doxorubicin-based protocols, for between 4 and 6 cycles: Doxorubicin and Dacarbazine (AD regimen); Doxorubicin and Ifosfamide (AI regimen); or Doxorubicin and Cisplatin (AC regimen). Subcutaneous 6mg of pegylated G-CSF (pegfilgrastim-jmdb, Fulphila) will be administered at 24h following chemotherapy. Allocation to study groups: Study patients will be randomly allocated (1:1) to one of the two study treatment arms: Group A, undergoing the acupuncture intervention at the 1st chemotherapy cycle; no acupuncture at the 2nd cycle; intervention at the 3rd; and so on. Group B: No intervention at the 1st cycle; acupuncture intervention at the 2nd cycle; and so on. T
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age 18-65 years * diagnosed with sarcoma of any stage * scheduled for doxorubicin-based chemotherapy * function ECOG status score of 0-1
Exclusion criteria
* not fulfilling all inclusion criteria * unwilling or unable to provide written informed consent for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of chemotherapy-induced febrile neutropenia-related hospitalization | 3 weeks |
| Duration of chemotherapy-induced febrile neutropenia-related hospitalization | 3 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Dose Intensity of Chemotherapy Regimen | 3 weeks | Actual vs. planned dosage and interval between cycles |
| G-CSF-related muscle and bone pain | 3 wseks | Patient-reported outcome measures |
| Quality of life-related outcomes: Quantitative Assessment | 3 weeks | Patient-reported outcome measures |
| Quality of life-related outcomes: Qualitative Assessment | 3 weeks | MYCaW narratives |
| Adverse effects of study intervention | 3 weeks | Patient medical files |
Countries
Israel
Contacts
CONTACTNoah Samuels, MD
PRINCIPAL_INVESTIGATORNoah Samuels, MD
Shaare Zeded Medical Center, Jerusalem, Israel
Outcome results
None listed